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Not yet recruiting NCT07493018

Effect of Hand Puppet and Squeeze Toys on IV Placement in Pediatric Oncology Patients

No phase Interventional Pediatric Hematology Pediatric Oncology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Performing a Hand Puppet to Music, Hand Squeezing Soft Toy (Squishy).
Who it may be relevant to
Registry conditions: Pediatric Hematology, Pediatric Oncology. Basic parameters: 6 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Hand Puppet and Squeeze Toy Techniques on Fear, Emotional Expression, and Procedure Success During Peripheral IV Catheter Placement in Pediatric Hematology-Oncology Patients: A Randomized Controlled Trial

Overview

This randomized controlled trial investigates hand puppet and squeeze toy techniques to reduce fear, emotional distress, and procedure time, and improve IV catheter placement success in 90 pediatric hematology-oncology patients (ages 6-10). Participants will be randomized into three groups: hand puppet, squeeze toy, or control. Outcomes include fear, emotional expression, procedure duration, number of attempts, and first-attempt success.

Interventions

  • Other Performing a Hand Puppet to Music
    Children interact with a hand puppet chosen according to their preference during IV catheter placement. The puppet's playful movements and music aim to distract and reduce fear and emotional distress.
  • Other Hand Squeezing Soft Toy (Squishy)
    Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention, reduces fear and distress, and helps them keep the procedure hand still. The toy is chosen by the child, hygienically managed, and given as a gift afterward. This simple, low-cost intervention aims to improve cooperation and IV placement success.

Primary outcome measures

  • Procedure duration [Time frame: During procedure]
  • Number of IV catheter attempts: [Time frame: During the IV procedure]
Secondary outcome measures (2)
  • Children's Fear Scale [Time frame: Measured before and immediately after IV catheter placement]
  • Children's Emotional Manifestation Scale [Time frame: During procedure]

Eligibility criteria

Inclusion criteria

Children aged 6-10 years with a pediatric hematology or oncology diagnosis.

Cognitively able to understand instructions during the procedure.

Require peripheral IV catheter placement as determined by the healthcare team.

Difficult Intravenous Access (DIVA) Score ≥4.

Child and parent/guardian willing to participate.

Exclusion criteria

Physical condition preventing use of a squeeze toy.

Cognitive or developmental disorders preventing understanding of procedural instructions.

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2. PMID 39002409
  • Gerceker GO, Bektas I, Yardimci F. The effects of virtual reality and stress ball distraction on procedure-related emotional appearance, pain, fear, and anxiety during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:197-204. doi: 10.1016/j.pedn.2024.08.029. Epub 2024 Sep 17. PMID 39293201

Identifiers

NCT: NCT07493018 · AkdenizUnOncology

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗